1. Field of the Invention
The present invention relates to a method of making a hard-candy based pharmaceutical lozenge which continuously and efficiently dispenses an antacid preparation in a highly palatable manner, and a lozenge made by such a process.
2. Description of the Prior Art
A wide variety of conditions, such as stress, poor dietary habits, and chemical or drug stimulation, can result in the overproduction and accumulation of acidic substances in the gastrointestinal tract. These acidic substances can concentrate particularly in the stomach and esophagus causing physical discomfort, often serious. .This condition may pose long-term deleterious physiological effects such as the onset of ulcerous conditions. An excellent summary of the effects of acid on the gastrointestinal tract is provided by W. Ganet, "Antacid Products", Handbook of Nonprescription Drugs, Sixth Edition, 1982, Chapter 3, pages 19-27.
Various treatment means may be undertaken by those afflicted with gastric discomfort. Among them are exercise, stress-reduction techniques, behavior modification, and pharmaceutical therapy.
Each of these treatment regimens has a similar disadvantage--a lack of positive incentive to continuously undergo therapy. Exercise requires physical exertion, stress-reduction techniques such as massage, counseling, and sedative drug therapy are expensive, time-consuming, and often invasive. Behavior modification is unpredictable, and prescription pharmaceutical preparations are expensive. Nonprescription remedies may also be expensive to manufacture on a large scale or, more importantly, carry the medicament stigma of a foul or unpleasant taste, texture or feel.
Prior art antacids, one of the most popular being marketed under the familiar trademarks of MYLANTA.RTM., are available for oral pharmaceutical treatment of ailments resulting from excess stomach acid. However, common complaints arising from these products are the gritty or chalky taste from the antacid portion of the medicament, leading to less continuous use (noncompliance) and consequently less effective treatment.
Various solutions have been proposed for this taste-texture problem's solution. Some of these solutions are as follows:
U.S. Pat. No. 4,425,332, issued on Jan. 10, 1984 to James, and is incorporated herein by reference. James discloses that oral antacid compositions usually have the salts, hydroxides, or carbonates of aluminum, calcium, or magnesium as active antacid ingredients.
To overcome the gritty and chalky taste/feel of the antacid, James discloses finely dividing the solid antacid and combining it with a flavored base, in the form of a fondant ("creamy") confectionery, in the texture of a candy bar or soft sweet. The antacid may also be incorporated in an edible coating, or in a cake-like mixture.
U.S. Pat. No. 4,910,023, issued on Mar. 20, 1990 to Botzolakis et al., is incorporated by reference. Botzolakis discloses the masking of hygroscopic malflavored drugs by a wet granulation process followed by drying which coats the drug particles with silicon dioxide to mask unpleasant tastes.
U.S. Pat. No. 4,396,604, issued on Aug. 2, 1983 to Mitra, and is incorporated herein by reference. Mitra discloses a simethicone antacid lozenge, and a batch method of combining simethicone, an antiflatulent, with an antacid, in a lozenge of hard candy in a manner by which the simethicone retains its antiflatulent properties. The Mitra simethicone lozenge, as disclosed, describes the composition as containing from 55-90% of sucrose solids and 10-45% of corn syrup with the simethicone; noncariogenic candy compositions with the simethicone; and candy compositions containing sugar alcohols with the simethicone.
U.S. Pat. No. 4,163,777 issued Aug. 7, 1979, also to Mitra. Mitra '777 discloses an antacid-containing matrix formed by compression which is said to be slowly-dissolving, and a method of treating patients using the slowly-dissolving lozenge composition. The lozenge is formed from a matrix including a sugar or sugar alcohol; a gel-forming swelling agent; and a water-insoluble lipid material.
While these prior art disclosures may be effective in theory, none has disclosed or contemplated this method of making a lozenge containing antacid which is inexpensive, has exceptional efficacy, and has a taste pleasing enough to provide the desired positive reinforcement to encourage compliance with an effective treatment regimen. The applicants have invented a novel method of manufacturing lozenges which have excellent taste properties, and are simple and cost effective to manufacture.